Assessment of the SYNOVIUM HCS Device for knee osteoarthritis
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
This study is testing a new device for knee osteoarthritis to see if it helps reduce pain and improve movement after receiving a hyaluronic acid injection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | LCA Pharmaceutical Industry-sponsored |
| Locations | 1 site (Saint-Brieuc) |
| Trial ID | NCT06087705 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and performance of the SYNOVIUM HCS device in patients with gonarthrosis. Participants will receive an intra-articular injection of hyaluronic acid and will be monitored over a 6-month follow-up period. Data on pain and disability will be collected before and after the injection to assess the device's effectiveness. The study aims to gather real-life data to better understand the outcomes associated with this treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with radiologically confirmed gonarthrosis and moderate walking pain who are scheduled to receive a SYNOVIUM HCS injection.
Not a fit: Patients with recent viscosupplementation or corticosteroid injections, inflammatory arthritis, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of SYNOVIUM HCS for alleviating knee pain in osteoarthritis patients.
How similar studies have performed: Other studies have shown positive outcomes with hyaluronic acid injections for knee osteoarthritis, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient * Patient with radiologically characterized gonarthrosis (stages Kellgren \& Lawrence grades I to III) * Patient with walking pain (WOMAC A1) at least equal to 2 on the Likert scale 0-4 * Patient to benefit from an injection of SYNOVIUM HCS as part of his treatment * Patient agreeing to participate in the study * Patient affiliated to a social security scheme or benefiting from such a scheme Exclusion Criteria: * Viscosupplementation less than 6 months old * Intra-articular corticosteroid injection less than 2 months old * Inflammatory arthritis or active infectious of the knee studied * History of surgery of the lower limb concerned * Kellgren \& Lawrence grades not defined * Known hypersensitivity to hyaluronic acid or chondroitin sulfate * Pregnant or breastfeeding women * Patient under guardianship, curatorship or judicial safeguard * Patient participating in another clinical investigation, at the time of inclusion
Where this trial is running
Saint-Brieuc
- CRRF en Milieu Marin de Trestel — Saint-Brieuc, France (Recruiting)
Study contacts
- Principal investigator: Dominique BARON — CRRF en Milieu Marin de Trestel
- Study coordinator: Patrice VINCENT
- Email: pvin@lca-pharma.com
- Phone: 02 37 33 39 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.